|By Business Wire||
|March 20, 2014 10:44 AM EDT||
The pharmaceutical community, health care organizations, and software providers are coming together at the OASIS open standards consortium to define a machine-readable content classification standard for the interoperable exchange of clinical trial data via content management systems. The work of the new OASIS Electronic Trial Master File (eTMF) Standard Technical Committee will promote interoperability across diverse computing platforms and cloud networks within the clinical trials community.
“We’re responding to a growing global need for a technology standard that can support formal representation and exchange of clinical trials eTMF content. Our goal is to enhance information interoperability among stakeholders,” said Zack Schmidt of SureClinical, chair of the OASIS eTMF Standard Technical Committee. “The breadth and stature of the organizations advancing this work clearly indicate there’s a real need for this standard.”
The OASIS eTMF work will enable content to be exchanged through cloud, networks, or physical media. Members will define an eTMF content classification model (including a standards-based vocabulary and content classification ontology), a set of content classification policies, and an eTMF Data Model.
The eTMF Standard framework will be a 'standard based on standards.’ It will support required documents from multiple regulatory agencies, published vocabulary references, and key industry standards. The OASIS work will be take place in two phases. The technology phase will build on the content classification specification and core terms contributed to OASIS by CareLex with input from the National Cancer Institute’s Enterprise Vocabulary Services. The vocabulary phase will build on the TMF Reference Model produced by the Document and Records Management DIA Community. It will utilize a W3C semantic web-based ontology to classify content as well as a controlled vocabulary sourced primarily from the NCI Thesaurus, which includes terms from the Biomedical Research Integrated Domain Group (BRIDG) Model, the product of a collaboration among CDISC, NCI, HL7, and the U.S. FDA. Additional eTMF domain classification terms, some of which are not present in BRIDG, will be developed by the OASIS Technical Committee.
New members are encouraged to join the OASIS eTMF Standard Technical Committee at any time. Archives of the work are accessible to both members and non-members, and OASIS invites public review and comment on the work.
Support for OASIS eTMF Standard
Forte Research Systems
“As a provider of specialized software serving organizations engaged in clinical and translational research, Forte Research Systems is committed to the development and adoption of relevant technology standards like eTMF and to supporting the work of standards organizations like OASIS. We are particularly enthusiastic about this new OASIS effort because it promises a consistent organization and structure of TMF content enabling the exchange of common TMF elements with other software systems in this space.”
--Tony O'Hare, PhD, Co-Founder, VP Operations, & Chief Collaboration Office, Forte Research
Health Level Seven (HL7)
“HL7 is pleased to continue its collaborative efforts with OASIS by participating in the Electronic Trial Master File (eTMF) Standard. This initiative to support formal representation and exchange of clinical trials eTMF information is well aligned with the existing standard that was jointly developed by HL7 and CDISC for the Regulated Clinical Research Information Management (RCRIM) Biomedical Research Integrated Domain Group’s Domain Analysis Model for the clinical research domain and also leverages a long standing HL7 relationship with not only CDISC and OASIS but also the FDA and NLM.”
--John Quinn, CTO, HL7
“As a leading provider of life science solutions, Oracle recognizes that developing standards to support data exchange and interoperability is critical to the smooth flow of data between systems that participate in the clinical trial life cycle. The ability for eTMF systems to easily consume Trial Master File documents and exchange those documents seamlessly will greatly improve sponsor management of trial documentation and speed up preparation of trial artifacts used in regulatory submissions. Oracle is pleased to participate in this initiative.”
--Don Deutsch, VP, Chief Standards Officer, Oracle
"As a founding sponsor of the OASIS eTMF Technical Committee, SureClinical is excited to see the widespread industry adoption of OASIS open standards. As a provider of cloud-based eTMF applications, we are proud to partner in the development of this critical BioPharma initiative that accelerates delivery of new therapies globally by facilitating the paperless exchange of clinical trial content. We look forward to championing the OASIS eTMF Standard by implementing a compliant SureTrial® eTMF Cloud solution."
--Zachariah Schmidt, CEO, SureClinical
OASIS eTMF Technical Committee
OASIS is a non-profit, international consortium that drives the
development, convergence and adoption of open standards for the global
information society. OASIS promotes industry consensus and produces
worldwide standards for cloud computing, content technologies, security,
privacy, M2M, IoT, energy, and other areas. OASIS open standards offer
the potential to lower cost, stimulate innovation, grow global markets,
and protect the right of free choice of technology. OASIS members
broadly represent the marketplace of public and private sector
technology leaders, users, and influencers. The consortium has more than
5,000 participants representing over 600 organizations and individual
members in 65+ countries.
Even though it’s now Microservices Journal, long-time fans of SOA World Magazine can take comfort in the fact that the URL – soa.sys-con.com – remains unchanged. And that’s no mistake, as microservices are really nothing more than a new and improved take on the Service-Oriented Architecture (SOA) best practices we struggled to hammer out over the last decade. Skeptics, however, might say that this change is nothing more than an exercise in buzzword-hopping. SOA is passé, and now that people are ...
May. 24, 2015 09:00 AM EDT Reads: 3,586
You often hear the two titles of "DevOps" and "Immutable Infrastructure" used independently. In his session at DevOps Summit, John Willis, Technical Evangelist for Docker, will cover the union between the two topics and why this is important. He will cover an overview of Immutable Infrastructure then show how an Immutable Continuous Delivery pipeline can be applied as a best practice for "DevOps." He will end the session with some interesting case study examples.
May. 24, 2015 09:00 AM EDT Reads: 2,045
Docker is becoming very popular--we are seeing every major private and public cloud vendor racing to adopt it. It promises portability and interoperability, and is quickly becoming the currency of the Cloud. In his session at DevOps Summit, Bart Copeland, CEO of ActiveState, discussed why Docker is so important to the future of the cloud, but will also take a step back and show that Docker is actually only one piece of the puzzle. Copeland will outline the bigger picture of where Docker fits a...
May. 24, 2015 09:00 AM EDT Reads: 6,141
SYS-CON Media named Andi Mann editor of DevOps Journal. DevOps Journal is focused on this critical enterprise IT topic in the world of cloud computing. DevOps Journal brings valuable information to DevOps professionals who are transforming the way enterprise IT is done. Andi Mann, Vice President, Strategic Solutions, at CA Technologies, is an accomplished digital business executive with extensive global expertise as a strategist, technologist, innovator, marketer, communicator, and thought lea...
May. 24, 2015 09:00 AM EDT Reads: 1,794
There is little doubt that Big Data solutions will have an increasing role in the Enterprise IT mainstream over time. 8th International Big Data Expo, co-located with 17th International Cloud Expo - to be held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA - has announced its Call for Papers is open. As advanced data storage, access and analytics technologies aimed at handling high-volume and/or fast moving data all move center stage, aided by the cloud computing bo...
May. 24, 2015 08:45 AM EDT Reads: 1,781
"People are a lot more knowledgeable about APIs now. There are two types of people who work with APIs - IT people who want to use APIs for something internal and the product managers who want to do something outside APIs for people to connect to them," explained Roberto Medrano, Executive Vice President at SOA Software, in this SYS-CON.tv interview at Cloud Expo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
May. 24, 2015 08:30 AM EDT Reads: 4,260
The 5th International DevOps Summit, co-located with 17th International Cloud Expo – being held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA – announces that its Call for Papers is open. Born out of proven success in agile development, cloud computing, and process automation, DevOps is a macro trend you cannot afford to miss. From showcase success stories from early adopters and web-scale businesses, DevOps is expanding to organizations of all sizes, including the...
May. 24, 2015 08:30 AM EDT Reads: 4,210
Discussions about cloud computing are evolving into discussions about enterprise IT in general. As enterprises increasingly migrate toward their own unique clouds, new issues such as the use of containers and microservices emerge to keep things interesting. In this Power Panel at 16th Cloud Expo, moderated by Conference Chair Roger Strukhoff, panelists will address the state of cloud computing today, and what enterprise IT professionals need to know about how the latest topics and trends affec...
May. 24, 2015 08:15 AM EDT Reads: 1,632
The 17th International Cloud Expo has announced that its Call for Papers is open. 17th International Cloud Expo, to be held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, brings together Cloud Computing, APM, APIs, Microservices, Security, Big Data, Internet of Things, DevOps and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding bu...
May. 24, 2015 08:00 AM EDT Reads: 4,390
Compute virtualization has been transformational, yet security policy implementation and enforcement has lagged behind in agility and automation. There are a number of key considerations when implementing policy in private and hybrid clouds. In his session at 15th Cloud Expo, Malcolm Rieke, the Director of Product Management at Catbird, discussed the impact of this new paradigm and what organizations can do today to safely move to software-defined network and compute architectures, including: ...
May. 24, 2015 08:00 AM EDT Reads: 2,785
Cloud Foundry open Platform as a Service makes it easy to operate, scale and deploy application for your dedicated cloud environments. It enables developers and operators to be significantly more agile, writing great applications and deliver them in days instead of months. Cloud Foundry takes care of all the infrastructure and network plumbing that you need to build, run and operate your applications and can do this while patching and updating systems and services without any downtime.
May. 24, 2015 07:30 AM EDT Reads: 3,575
An effective way of thinking in Big Data is composed of a methodical framework for dealing with the predicted shortage of 50-60% of the qualified Big Data resources in the U.S. This holistic model comprises the scientific and engineering steps that are involved in accelerating Big Data solutions: problem, diagnosis, facts, analysis, hypothesis, solution, prototype and implementation. In his session at Big Data Expo®, Tony Shan focused on the concept, importance, and considerations for each of t...
May. 24, 2015 07:30 AM EDT Reads: 2,513
There has been a lot of discussion recently in the DevOps space over whether there is a unique form of DevOps for large enterprises or is it just vendors looking to sell services and tools. In his session at DevOps Summit, Chris Riley, a technologist, discussed whether Enterprise DevOps is a unique species or not. What makes DevOps adoption in the enterprise unique or what doesn’t? Unique or not, what does this mean for adopting DevOps in enterprise size organizations? He also explored differe...
May. 24, 2015 07:30 AM EDT Reads: 3,692
T-Mobile has been transforming the wireless industry with its “Uncarrier” initiatives. Today as T-Mobile’s IT organization works to transform itself in a like manner, technical foundations built over the last couple of years are now key to their drive for more Agile delivery practices. In his session at DevOps Summit, Martin Krienke, Sr Development Manager at T-Mobile, will discuss where they started their Continuous Delivery journey, where they are today, and where they are going in an effort ...
May. 24, 2015 07:00 AM EDT Reads: 1,559
Cloud and Big Data present unique dilemmas: embracing the benefits of these new technologies while maintaining the security of your organization's assets. When an outside party owns, controls and manages your infrastructure and computational resources, how can you be assured that sensitive data remains private and secure? How do you best protect data in mixed use cloud and big data infrastructure sets? Can you still satisfy the full range of reporting, compliance and regulatory requirements? In...
May. 24, 2015 07:00 AM EDT Reads: 4,422
The cloud is everywhere and growing, and with it SaaS has become an accepted means for software delivery. SaaS is more than just a technology, it is a thriving business model estimated to be worth around $53 billion dollars by 2015, according to IDC. The question is - how do you build and scale a profitable SaaS business model? In his session at 15th Cloud Expo, Jason Cumberland, Vice President, SaaS Solutions at Dimension Data, discussed the common mistakes businesses make when transitioning t...
May. 24, 2015 06:30 AM EDT Reads: 3,126
Are your Big Data initiatives resulting in Big Impact or Big Mess? In her session at Big Data Expo, Penelope Everall Gordon, Emerging Technology Strategist at 1Plug Corporation, shared her successes in improving Big Decision outcomes by building stories compelling to the target audience – and her failures when she lost sight of the plotline, distracted by the glitter of technology and the lure of buried insights. The cast of characters includes the agency head [city official? elected official?...
May. 24, 2015 06:30 AM EDT Reads: 3,420
In their session at @ThingsExpo, Shyam Varan Nath, Principal Architect at GE, and Ibrahim Gokcen, who leads GE's advanced IoT analytics, focused on the Internet of Things / Industrial Internet and how to make it operational for business end-users. Learn about the challenges posed by machine and sensor data and how to marry it with enterprise data. They also discussed the tips and tricks to provide the Industrial Internet as an end-user consumable service using Big Data Analytics and Industrial C...
May. 24, 2015 06:30 AM EDT Reads: 5,562
Big Data is amazing, it's life changing and yes it is changing how we see our world. Big Data, however, can sometimes be too big. Organizations that are not amassing massive amounts of information and feeding into their decision buckets, smaller data that feeds in from customer buying patterns, buying decisions and buying influences can be more useful when used in the right way. In their session at Big Data Expo, Ermanno Bonifazi, CEO & Founder of Solgenia, and Ian Khan, Global Strategic Positi...
May. 24, 2015 06:30 AM EDT Reads: 2,547
Storage administrators find themselves walking a line between meeting employees’ demands to use public cloud storage services, and their organizations’ need to store information on-premises for security, performance, cost and compliance reasons. However, as file sharing protocols like CIFS and NFS continue to lose their relevance, simply relying only on a NAS-based environment creates inefficiencies that hurt productivity and the bottom line. IT wants to implement cloud storage it can purchase a...
May. 24, 2015 06:30 AM EDT Reads: 2,869